Orange Book product · Generic (ANDA)
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
At a glance
Oct 29, 2024
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 29, 2024
1 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
CYCLOPHOSPHAMIDE
Strength
1GM/5ML (200MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
ANDA 216783
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CYCLOPHOSPHAMIDE
- 2023CYCLOPHOSPHAMIDEBrand (NDA)
NDA 217150 · SANDOZ
- 2023CYCLOPHOSPHAMIDEBrand (NDA)
NDA 217651 · BAXTER HLTHCARE CORP
- 2023FRINDOVYXBrand (NDA)
NDA 210852 · AVYXA HOLDINGS
- 2021CYCLOPHOSPHAMIDEBrand (NDA)
NDA 210735 · EUGIA PHARMA SPECLTS
- 2020CYCLOPHOSPHAMIDEBrand (NDA)
NDA 212501 · DR REDDYS
- 2013CYCLOPHOSPHAMIDEBrand (NDA)
NDA 203856 · HIKMA
- —CYTOXANBrand (NDA)
NDA 012142 · BAXTER HLTHCARE
- —CYTOXANBrand (NDA)
NDA 012141 · BAXTER HLTHCARE
- 2024CYCLOPHOSPHAMIDEGeneric (ANDA)
ANDA 218632 · HAINAN POLY
- 2024CYCLOPHOSPHAMIDEGeneric (ANDA)
ANDA 218644 · EPIC PHARMA LLC
- 2024CYCLOPHOSPHAMIDEGeneric (ANDA)
ANDA 218282 · EIRGEN
- 2023CYCLOPHOSPHAMIDEGeneric (ANDA)
ANDA 216958 · HIKMA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
